AQUARIUSAPS SERVER

K061214 · Terarecon,Inc. · LLZ · May 15, 2006 · Radiology

Device Facts

• Record ID: K061214
• Device Name: AQUARIUSAPS SERVER
• Applicant: Terarecon,Inc.
• Product Code: LLZ · Radiology
• Decision Date: May 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The AquariusAPS server receives medical images from medical imaging acquisition devices adhering to the DICOM protocol for image transfer such as EBT, CT, MRI, and other volumetric or planar medical imaging modalities, and performs digital image processing to derive certain information or new images from these image sets. The information or new images thus derived is transmitted using the DICOM protocol to other devices supporting this standard protocol. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Device Story

AquariusAPS server receives medical images (EBT, CT, MRI, volumetric/planar) via DICOM protocol; performs automated digital image processing; transmits derived images/data to other DICOM-compliant devices. Functions include: CT table/bony structure removal; centerline calculation for hollow organs/vessels; heart tissue isolation; parametric color overlay mapping for time-dependent scans; sphere-like structure identification; multi-planar/volume rendering (MPR, MIP, VR); image registration; volume calculation. Used in clinical environments; operated by healthcare professionals. Server automates pre-processing tasks to optimize user time, removing need for manual processing on review systems. Output viewed by clinicians on diagnostic workstations to assist in clinical decision-making and diagnostic workflows.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on technical feature comparison and performance of image processing functions consistent with predicate devices.

Technological Characteristics

Hardware: Standard off-the-shelf PC, Pentium III-class processor. OS: Windows 2000. Connectivity: DICOM protocol for image transfer. Processing: Automated image manipulation (MPR, MIP, VR, registration, segmentation). Software: Developed per FDA guidance for software in medical devices. Administration: Browser-based interface.

Indications for Use

Indicated for processing medical images (EBT, CT, MRI, volumetric/planar) received via DICOM protocol to derive new images or information for transmission to other DICOM-compliant devices. Contraindicated for primary interpretation of lossy compressed mammographic images or digitized film screen images.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• Aquarius Workstation (K011142)
• AquariusNET Server (K012086)
• Lung CAR (K041807)
• Colon CAR (K042674)
• Fusion 7D (K020546)

Submission Summary (Full Text)

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# 510(k) Premarket Notification

#### AquariusAPS Server Trade Name:

Common/Usual Name: Server for image processing and communication Classification Name: System, Image Processing

MAY 15 2006

#### Establishment Name and Registration Number:

Name: TeraRecon, Inc. Number: 2954793

#### Classification:

21 CFR § 892.2050, Picture Archiving and Communications System, Class II, proposed exempt, final rule pending.

90-LLZ ProCode:

#### Equivalent Device(s):

- 1. Aquarius Workstation-K011142 by TeraRecon Inc.
- 2. AquariusNET Server- K012086 by TeraRecon Inc.
- 3. Lung CAR-K041807 by Medicsight PLC.
- 4. Colon CAR-K042674 by Medicsight PLC.
- 5. Fusion 7D-K020546 by Mirada Solutions, Ltd.

Parts of these devices are substantially equivalent in terms of basic design, features and intended use.

#### Applicant/Sponsor Name/Address:

#### TeraRecon Inc.

2955 Campus Drive, Suite 325 San Mateo, CA 94403 Tel: [phone] FAX: [phone]

#### Contact Person:

Emilly Tojima Quality Assurance and Regulatory Affairs Manager TeraRecon Inc. 2955 Campus Drive, Suite 325 San Mateo, CA 94403 Tel: [phone]

#### Description of the Device:

The AquariusAPS server receives medical images from medical imaging acquisition devices adhering to the DICOM protocol for image transfer such as EBT, CT, MRI, and other volumetric or planar medical imaging modalities, and performs digital image processing to derive certain information or new images from these image sets. The information or new images thus derived is transmitted using the DICOM protocol to other devices supporting this standard protocol. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA."

The intended use of the device is to provide time-saving pre-processing of images to remove the need for an image review system to perform these activities while a user is waiting for processing to complete, to optimize the use of the user's time.

K061214
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### Hardware & Software Information

The AquariusAPS Server utilizes standard "off the shelf" personal computer systems as its hardware platform. The software requires the use of the Windows 2000 operating system, and a Pentium III - class processor or equivalent.

The software designed to control and manipulate the diagnostic images are based upon information and guidance found in the list of standards provided in Appendix III. In accordance with TeraRecon's software development procedures, the level of concern relative to this software has been determined through information obtained from the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005).

| Feature | Aquarius<br>APS | Aquarius<br>NET Server | Aquarius<br>Workstation | Lung CAR<br>Medicsight | Colon CAR<br>Medicsight | Fusion 7D<br>Mirada<br>Solutions |
|------------------------------------------------------------------------------------------------------------------------------|-----------------|------------------------|-------------------------|------------------------|-------------------------|----------------------------------|
| 2D, 3D Image Review | No | Yes | Yes | No | No | No |
| Removal of the CT table<br>from a CT examination | Yes | Yes | Yes | No | No | No |
| Removal of bony structures<br>from a CT examination | Yes | Yes | Yes | No | No | No |
| Calculation of a centerline<br>through a hollow organ or<br>structure, or vessels, for a<br>CT or MR scan | Yes | Yes | Yes | No | No | No |
| Isolation of tissue in the<br>vicinity of and including the<br>heart from a CT scan | Yes | No | Yes | No | No | No |
| Calculation of a parametric<br>color overlay map for time-<br>dependent a MR or CT scan | Yes | No | Yes | No | No | No |
| Identifying locations of<br>sphere-like structures in a<br>CT scan | Yes | No | Yes<br>(Manual) | Yes | Yes | No |
| Calculation of a set of<br>images in certain<br>orientations or planes using<br>MPR, MIP, VR or other<br>rending techniques. | Yes | Yes | Yes | No | No | No |
| Calculation of a<br>transformation to register<br>one set of images to another | Yes | Yes (Manual) | No | No | No | Yes |
| Calculation of the volume<br>of a certain structure,<br>possibly with time<br>dependence | Yes | No | Yes | No | No | No |
| Receiving images using<br>DICOM transfer protocols | Yes | Yes | Yes | Yes | Yes | Yes |
| Sending Images and other<br>data using DICOM transfer<br>protocols | Yes | Yes | Yes | Yes | Yes | Yes |
| Performing actions based<br>on DICOM tags contained<br>in images received by<br>DICOM | Yes | Yes | No | No | No | No |
| Administration control<br>through a browser-based<br>interface | Yes | Yes | No | No | No | No |
| Export of images and image<br>sequences in a variety of<br>formats | Yes | Yes | Yes | Yes | Yes | Yes |

#### Feature Comparison Table

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

### MAY 15 2005

TeraRecon, Inc. % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087

Re: K061214

Trade/Device Name: AquariusAPS Server Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 1, 2006 Received: May 2, 2006

Dear Mr. Lehtonen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "FDA Centennial" in the center. The logo also includes the years "1906-2006" at the top. There are stars at the bottom of the logo. The text is surrounded by a circular border with additional text.

Protecting and Promoting Public Health

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

San 1942 2

Enclosure

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### DEVICE NAME: AquariusAPS

### INDICATIONS FOR USE:

The AquariusAPS server receives medical images from medical imaging acquisition devices The Aquartish D server rocercol for image transfer such as EBT, CT, MRI, and other adming to the Droom medical imaging modalities, and performs digital image processing to derive certain information or new images from these image sets. The information or new images thus derived is transmitted using the DICOM protocol to other devices supporting this standard protocol.

Lossy compressed mammographic images and digitized film screen images must not be reviewed LUSS voluptessou interpretations. Mammographic images may only be interpreted using an FDA 101 primal y migrous at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

一次的一个人,一个人生

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Chroydon
(Division Sign-Off)

Division of Reproductive, Abd and Radiological Devices 510(k) Number